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`
`Financial report for the period 1 January 2022 to 30 June 2022
`
`3 August 2022
`
`
`
`
`
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`
`
`
`
`
`
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`Novo Nordisk's sales increased by 25% in Danish kroner and by 16% at constant
`exchange rates to DKK 83.3 billion in the first six months of 2022
`
`• Operating profit increased by 26% in Danish kroner and by 14% at constant exchange rates (CER) to DKK 37.5 billion.
`• Sales in International Operations increased by 15% in Danish kroner (10% at CER), and sales in North America
`Operations increased by 36% in Danish kroner (24% at CER).
`• Sales within Diabetes and Obesity care increased by 28% in Danish kroner to DKK 72.7 billion (19% at CER), mainly
`driven by GLP-1 diabetes sales growth of 57% in Danish kroner (45% at CER). Rare disease sales increased by 6%
`measured in Danish kroner (unchanged at CER).
`• Obesity care sales grew by 99% in Danish Kroner (84% at CER). Novo Nordisk expects to make all Wegovy® dose
`strengths available in the US towards the end of 2022.
`• Within R&D, Novo Nordisk has now successfully completed five phase 3a trials with insulin icodec, a long-acting once-
`weekly insulin. Based on a recommendation from an independent Data Monitoring Committee following an interim
`analysis, the SELECT cardiovascular outcomes trial continues in accordance with the trial protocol.
`
`• For the 2022 outlook, sales growth is now expected to be 12-16% at CER and operating profit growth is now expected
`to be 11-15% at CER. Sales and operating profit growth reported in Danish kroner are now expected to be 9 and 14
`percentage points higher than at CER, respectively.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`* CER: Constant exchange rates (average 2021).
`
`H1 2022
`
`H1 2021
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`83,296
`37,538
`
`27,528
`12.08
`
`
`
`
`
`
`
`66,845
`29,761
`
`24,746
`10.71
`
` 25%
` 26%
`
` 11%
` 13%
`
` 16%
` 14%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the sales growth in the first half of 2022. The
`growth is driven by increasing demand for GLP-1 based diabetes treatments, especially Ozempic®. Our obesity treatments
`are also contributing to growth as more people living with obesity are being treated and the Obesity care market
`continues to expand. The performance in the first six months has enabled us to raise our outlook for the full year."
`
`On 3 August 2022 at 19.30 CEST, corresponding to 1.30 pm EDT, an earnings call will be held. Investors will be able to listen in
`via a link on novonordisk.com, which can be found under ‘Investors’.
`
`Novo Nordisk A/S
`Investor Relations
`
`Novo Allé
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 2 of 34
`
`STRATEGIC ASPIRATIONS
`
`STRATEGIC ASPIRATIONS 2025
`The strategic aspirations are objectives that Novo Nordisk intends to work towards and are not a projection of Novo
`Nordisk's financial outlook or expected growth. Novo Nordisk intends to describe how its activities develop in relation to
`each of the four dimensions on an ongoing basis.
`
`Performance highlights for the first six months of 2022 (blue indicates second-quarter development):
`Purpose and sustainability
`Innovation and therapeutic focus
`Progress towards zero environmental impact:
`Further raise innovation bar for diabetes treatment:
`Approval of Ozempic® 2.0 mg in the US
`•
`Carbon emissions from operations and transportation
`•
`increased by 49% compared to first half of 2021 and
`•
`Successful completion of five phase 3 trials with once-weekly
`decreased by 19% compared to the first half of 2019
`insulin icodec
`Phase 1 trial with Ideal Pump insulin successfully completed
`Phase 1 trial initiated with a once-daily oral GLP-1/GIP
`agonist
`
`•
`•
`
`Adding value to society:
`•
`Progress on 'Defeat Diabetes' strategy:
`◦ Medical treatment provided to 35.1 million people living
`with diabetes
`Reaching 24 countries and more than 34,000 children in
`Changing Diabetes® in Children programme
`Five months’ supply of diabetes and haemophilia
`medication donated to the Ukrainian Ministry of Health
`Positive scientific opinion from EMA on human insulin with
`more flexible storage without refrigeration
`
`◦
`
`•
`
`•
`
`Stre Develop superior treatment solutions for obesity:
`•
`STEP TEENs phase 3 trial successfully completed
`•
`Phase 1 initiation with oral amycretin
`
`the
`
`Strengthen and progress Rare disease pipeline:
`•
`Concizumab phase 3 trial successfully completed in people
`with haemophilia A and B with inhibitors
`Phase 2 trial initiated with NDec in sickle cell disease
`
`•
`
`Establish presence in Other serious chronic diseases:
`•
`Phase 2 trial initiated with NNC6019 in cardiomyopathy
`
`Being recognised as a sustainable employer:
`•
`Share of women in senior leadership positions has
`increased to 38% from 35% in the first half of 2021
`
`
`
`Commercial execution
` Strengthen diabetes leadership to more than one-third:
`• Diabetes value market share increased by 1.5 percentage
`points to 31.0% (MAT)
`
` More than DKK 25 billion in Obesity care sales by 2025:
`• Obesity care sales increased by 84% (CER) to DKK 7.0 billion
`
`Financials
`Deliver solid sales and operating profit growth:
`•
`Sales growth at 16% (CER)
`International Operations sales growth of 10% (CER)
`•
`• US sales growth of 23% (CER) with 71% of sales coming
`from products launched since 2015
`• Operating profit growth of 14% (CER)
`
` Secure a sustained growth outlook for Rare disease:
`•
`Rare disease sales were unchanged at (CER) at DKK 10.6
`billion
`
` Drive operational efficiencies:
`•
`Continued productivity gains in Product Supply
`
`Enable attractive capital allocation to shareholders:
`•
`Free cash flow of DKK 42.7 billion
`• DKK 27.6 billion returned to shareholders during the first
`half of 2022
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 3 of 34
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR THE FIRST SIX MONTHS OF 2022
`
`PROFIT AND LOSS
`
`H1 2022
`
`H1 2021
`
`(Amounts are in DKK million, except for earnings per share and employees)
`
` % change
` H1 2022 to
` H1 2021
`
` % change
` H1 2022 to
` H1 2021 at
`CER
`
`Net sales
`
`Gross profit
`Gross margin
`Sales and distribution costs
`Percentage of sales
`Research and development costs
`Percentage of sales
`Administrative costs
`Percentage of sales
`Other operating income and expenses
`
`Operating profit
`Operating margin
`Financial items (net)
`
`Profit before income taxes
`Income taxes
`Effective tax rate
`Net profit
`Net profit margin
`
`OTHER KEY NUMBERS
`Depreciation, amortisation and impairment losses
`Capital expenditure (PP&E)
`Net cash generated from operating activities
`Free cash flow
`Total assets
`Equity
`Equity ratio
`Average number of diluted shares outstanding (million)
`Diluted earnings per share / ADR (in DKK)
`Full-time equivalent employees end of period
`
` 83,296
`
` 66,845
`
` 70,310
` 84.4%
`(21,023)
` 25.2%
`(10,329)
` 12.4%
`(1,961)
` 2.4%
`541
`
`
`
`
`
`
`
`
`
` 55,487
` 83.0%
`(16,257)
` 24.3%
`(7,888)
` 11.8%
`(1,836)
` 2.7%
`255
`
`
`
`
`
`
`
`
`
` 37,538
` 45.1%
`(2,824)
`
`
`
` 34,714
`(7,186)
`
` 20.7%
` 27,528
` 33.0%
`
`3,286
`
`3,955
`
` 47,547
` 42,725
` 218,928
` 74,452
` 34.0%
` 2,279.7
`
`12.08
` 50,816
`
` 29,761
` 44.5%
`1,094
`
`
`
` 30,855
`(6,109)
`
` 19.8%
` 24,746
` 37.0%
`
`2,594
`
`3,111
`
` 36,510
` 32,696
` 158,095
` 65,559
` 41.5%
` 2,310.9
`
`10.71
` 45,971
`
` 25%
`
` 27%
`
` 29%
`
` 31%
`
` 7%
`
` 112%
`
` 26%
`
` (358%)
`
` 13%
` 18%
`
` 11%
`
` 27%
` 27%
` 30%
` 31%
` 38%
` 14%
`
` (1%)
` 13%
` 11%
`
` 16%
`
` 17%
`
` 22%
`
` 26%
`
` 3%
`
` 92%
`
` 14%
`
`N/A
`
`N/A
`N/A
`
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`N/A
`N/A
`
`These unaudited consolidated financial statements for the first six months of 2022 have been prepared in accordance
`with IAS 34 ‘Interim Financial Reporting’ and additional Danish disclosure requirements for listed companies. The
`accounting policies adopted in the preparation are consistent with those applied in the Annual Report 2021 of Novo
`Nordisk.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 4 of 34
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 25% measured in Danish kroner and by 16% at CER in the first six months of 2022, driven by Diabetes care
`sales growth of 15% (CER) and Obesity care sales growth of 84% (CER). Rare disease sales were unchanged at CER.
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
` Sales H1 2022
`DKK million
`
` Sales H1 2021
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`Rybelsus®
`Ozempic®
`Victoza®
`Total GLP-1
`Long-acting insulin
` -   Tresiba®
` -   Xultophy®
` -   Levemir®
`Premix insulin
` -   Ryzodeg®
` -   NovoMix®
`Fast-acting insulin
` -   Fiasp®
` -   NovoRapid®
`Human insulin
`Total insulin
`Other Diabetes care1
`Total Diabetes care
`Wegovy®
`Saxenda®
`Total Obesity care
`Diabetes and Obesity care total
`Rare disease segment
`Rare blood disorders2
` - Haemophilia A
` - Haemophilia B
` -  NovoSeven®
`Rare endocrine disorders3
`Other Rare disease4
`Rare disease total
`
`Total sales
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4,235
`26,384
`6,032
`36,651
`8,900
`4,833
`1,408
`2,659
`5,513
`1,352
`4,161
`8,729
`1,013
`7,716
`4,163
`27,305
`1,714
`65,670
`2,585
`4,460
`7,045
`72,715
`
`5,940
`1,184
`339
`4,289
`3,743
`898
`10,581
`
`83,296
`
`1,674
`14,097
`7,606
`23,377
`8,971
`4,557
`1,326
`3,088
`5,668
`841
`4,827
`8,808
`837
`7,971
`4,576
`28,023
`1,919
`53,319
`85
`3,458
`3,543
`56,862
`
`5,401
`1,120
`309
`3,855
`3,779
`803
`9,983
`
`66,845
`
`1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
`2) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®.
`3) Primarily Norditropin®.
`4) Primarily Vagifem® and Activelle®.
`
` 153%
` 87%
` (21%)
` 57%
` (1%)
` 6%
` 6%
` (14%)
` (3%)
` 61%
` (14%)
` (1%)
` 21%
` (3%)
` (9%)
` (3%)
` (11%)
` 23%
`—
` 29%
` 99%
` 28%
`
` 10%
` 6%
` 10%
` 11%
` (1%)
` 12%
` 6%
`
` 25%
`
`
`
` 134%
` 73%
` (26%)
` 45%
` (6%)
` 0%
` 3%
` (19%)
` (8%)
` 55%
` (19%)
` (6%)
` 16%
` (9%)
` (15%)
` (8%)
` (16%)
` 15%
`—
` 21%
` 84%
` 19%
`
` 3%
` 1%
` 6%
` 3%
` (5%)
` 7%
` 0%
`
` 16%
`
` 21%
` 93%
` (18%)
` 96%
` (5%)
` 0%
` 0%
` (5%)
` (4%)
` 4%
` (8%)
` (5%)
` 1%
` (6%)
` (6%)
` (20%)
` (3%)
` 73%
` 20%
` 7%
` 27%
` 100%
`
` 2%
` 0%
` 0%
` 2%
` (2%)
` 0%
` 0%
`
` 100%
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 5 of 34
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 23% measured in Danish kroner and by 15% at CER to DKK 65,670 million driven by
`GLP-1 growth. Novo Nordisk has improved the global diabetes value market share over the last 12 months from 29.6% to
`31.0% in line with the aspiration of strengthening the Diabetes care leadership, aiming at reaching a global value market
`share of more than one-third in 2025. The market share increase was driven by market share gains in both International
`Operations and North America Operations.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from May 2021 and
`May 2022 provided by the independent data provider IQVIA. EMEA covers Europe, the Middle East and Africa; Region
`China covers mainland China, Hong Kong and Taiwan, and Rest of World covers all other countries except for North
`America.
`
`Diabetes care, development per geographical area
`
`Novo Nordisk’s share of the total
`diabetes market (value, MAT)
`
`Diabetes care, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`May
`2022
` 31.0%
` 25.8%
` 29.0%
` 32.9%
` 17.5%
` 32.8%
` 32.7%
`
`May
`2021
` 29.6%
` 24.0%
` 28.0%
` 32.7%
` 14.0%
` 31.6%
` 31.6%
`
` Sales H1 2022
`DKK million
`65,670
`33,670
`16,734
`8,032
`8,904
`32,000
`29,742
`
`Growth
`at CER
` 15%
` 10%
` 12%
` (7%)
` 25%
` 21%
` 20%
`
`Source: IQVIA, May 2022 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk Diabetes care sales
`in the area. **Data for mainland China, excluding Hong Kong and Taiwan. *** Data for Rest of World available for seven markets representing approximately 70% of total Novo
`Nordisk’s Diabetes care sales in the area.
`
`GLP-1 therapy for type 2 diabetes
`Sales of GLP-1 products for type 2 diabetes (Rybelsus®, Ozempic® and Victoza®) increased by 57% measured in Danish
`kroner and by 45% at CER to DKK 36,651 million. The GLP-1 segment’s value share of the total diabetes market has
`increased to 29.3% compared with 24.0% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 54.8% value market share, an increase of 3.3 percentage points compared to 12 months ago.
`
`GLP-1, development per geographical area
`
`Novo Nordisk's share of the
`diabetes GLP-1 market (value, MAT)
`
`GLP-1, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`May
`2022
` 54.8%
` 61.3%
` 59.4%
` 63.1%
` 66.2%
` 53.8%
` 52.9%
`
`May
`2021
` 51.5%
` 56.1%
` 56.8%
` 84.7%
` 48.0%
` 50.8%
` 50.1%
`
` Sales H1 2022
`DKK million
`36,651
`12,013
`6,815
`1,672
`3,526
`24,638
`23,021
`
`Growth
`at CER
` 45%
` 53%
` 35%
` 83%
` 92%
` 41%
` 39%
`
`Source: IQVIA, May 2022 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk GLP-1 sales in the
`area. **Data for mainland China, excluding Hong Kong and Taiwan. ***Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk
`Diabetes care sales in the area.
`Rybelsus® sales increased by 153% measured in Danish kroner and by 134% at CER to DKK 4,235 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World. Rybelsus® has now been launched in 39 countries.
`
`Ozempic® sales increased by 87% measured in Danish kroner and by 73% at CER to DKK 26,384 million. Sales growth was
`driven by both North America Operations and International Operations. Ozempic® has been launched in 75 countries.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 6 of 34
`
`Victoza® sales decreased by 21% measured in Danish kroner and by 26% at CER to DKK 6,032 million as the GLP-1 market
`is moving towards once-weekly and tablet-based treatments. The sales decline was driven by both North America
`Operations and International Operations.
`
`International Operations
`Sales of GLP-1 diabetes products in International Operations increased by 60% measured in Danish kroner and by 53% at
`CER. Sales growth is driven by all geographical areas. The value share of the GLP-1 class of the total diabetes market has
`increased to 15.5% from 11.9% 12 months ago. Novo Nordisk is the market leader with a value market share of 61.3%.
`
`EMEA
`Sales in EMEA increased by 37% measured in Danish kroner and by 35% at CER. The sales growth reflects the uptake of
`Ozempic® and Rybelsus®, partially offset by lower sales of Victoza®. Rybelsus® has been launched in 32 countries in EMEA.
`Novo Nordisk remains the market leader in EMEA with a value market share of 59.4%.
`
`Region China
`Sales in Region China increased by 101% measured in Danish kroner and by 83% at CER. The sales growth reflects the
`uptake of Ozempic®, partially offset by lower sales of Victoza®. As of 1 January 2022, Ozempic® has been included on the
`National Reimbursement List in China. The GLP-1 class' share of the overall diabetes market value in Region China
`increased to 7.8% from 4.2% 12 months ago.
`
`Rest of World
`Sales in Rest of World increased by 103% measured in Danish kroner and by 92% at CER. The sales growth reflects
`increased sales of Ozempic® and following the Rybelsus® launch in Japan, partially offset by Victoza®. Novo Nordisk remains
`the market leader with a value market share of 66.2%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 55% measured in Danish kroner and by 41%
`at CER. Novo Nordisk is the market leader with a 53.8% value market share compared to 50.8% 12 months ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 34.0% compared to 28.4%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of more than 35% in the second
`quarter of 2022 compared to the second quarter of 2021 as well as market share gains for Ozempic® and Rybelsus®. The
`combined Novo Nordisk GLP-1 new-to-brand prescription market share is now 65.7% driven by Ozempic® with 51.9% and
`Rybelsus® with 10.1%. Novo Nordisk is the market leader with 56.4% measured on total monthly prescriptions for the
`combined GLP-1 portfolio.
`
`Sales of GLP-1 in the US increased by 39% at CER. The sales increase was driven by continued uptake of Ozempic® and
`Rybelsus®, partially offset by declining Victoza® sales. GLP-1 sales growth was negatively impacted by rebate
`enhancements as well as unfavourable channel and payer mix.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 7 of 34
`
`Insulin
`Sales of insulin decreased by 3% measured in Danish kroner and by 8% at CER to DKK 27,305 million. Sales decline at CER
`was driven by declining sales in the US and Region China.
`
`Insulin, development per geographical area
`
`Novo Nordisk’s share of the total
`insulin market (volume, MAT)
`
`Insulin, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`May
`2022
` 47.1%
` 50.3%
` 47.8%
` 50.5%
` 57.1%
` 38.4%
` 37.9%
`
`May
`2021
` 47.2%
` 50.2%
` 47.5%
` 50.8%
` 57.3%
` 39.2%
` 39.0%
`
` Sales H1 2022
`DKK million
`27,305
`20,326
`9,558
`5,669
`5,099
`6,979
`6,411
`
`Growth
`at CER
` (8%)
` (5%)
` 1%
` (17%)
` 1%
` (18%)
` (19%)
`
`Source: IQVIA, May 2022 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk insulin sales in the
`area. **Data for mainland China, excluding Hong Kong and Taiwan. ***Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk
`Diabetes care sales in the area.
`International Operations
`Sales of insulin in International Operations remained unchanged in Danish kroner and decreased by 5% at CER. The sales
`decline at CER was driven by lower insulin sales in Region China due to implementation of Volume Based Procurement.
`
`EMEA
`Sales of insulin in EMEA increased by 2% measured in Danish kroner and by 1% at CER. The sales growth at CER was mainly
`driven by Tresiba®, Fiasp® and Ryzodeg®, partially countered by NovoMix®, human insulin, Xultophy® and NovoRapid®.
`Novo Nordisk has a volume market share of 47.8% of the total insulin market.
`
`Region China
`Sales of insulin in Region China decreased by 9% measured in Danish kroner and by 17% at CER. The sales decline was
`driven by NovoMix®, human insulin, Levemir® and NovoRapid® due to the implementation of Volume Based Procurement
`from May 2022. The sales decline was partially countered by Ryzodeg®, Tresiba® and Xulthopy®. Novo Nordisk has a
`volume market share of 50.5% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World increased by 7% measured in Danish kroner and by 1% at CER. The sales growth at CER
`was driven by all insulin products except for human insulin, NovoMix® and Levemir®. Novo Nordisk has a volume market
`share of 57.1% of the total insulin market.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 9% measured in Danish kroner and by 18% at CER. The sales
`decrease in the US was driven by lower realised prices due to rebate enhancements and channel and payer mix as well as
`a decline in volume with the US insulin volume market declining 3% compared to the first half of 2021. Novo Nordisk has a
`volume market share of 37.9% of the total US insulin market.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 8 of 34
`
`Obesity care, sales development
`Sales of Obesity care products, Saxenda® and Wegovy® increased by 99% measured in Danish kroner and by 84% at CER
`to DKK 7,045 million. Sales growth was driven by both North America Operations and International Operations. Saxenda®
`has been launched in 65 countries, and Wegovy® was launched in the US in June 2021. The volume growth of the global
`branded obesity market was 63%.
`
`Obesity care, development per geographical area
`
`Obesity care, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales H1 2022
`DKK million
`7,045
`2,480
`1,516
`78
`886
`4,565
`4,345
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 84%
` 60%
` 78%
`—
` 29%
` 102%
` 110%
`
`International Operations
`Sales of Saxenda® in International Operations increased by 66% measured in Danish kroner and by 60% at CER driven by
`increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 57.8% in the branded
`obesity prescription drug market.
`
`EMEA
`Sales of Saxenda® in EMEA increased by 81% measured in Danish kroner and by 78% at CER. Novo Nordisk currently has a
`value market share of 79.1% in the branded obesity prescription drug market.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 38% measured in Danish kroner and by 29% at CER. Saxenda® has been
`launched in 19 countries in Rest of World. Novo Nordisk currently has a value market share of 44.5% in the branded
`obesity prescription drug market.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 123% measured in Danish kroner and by 102% at
`CER. Novo Nordisk now has a value market share of 92.7% in the branded anti-obesity prescription drug market in North
`America. Wegovy® was made available to patients in June 2021 and broad commercial formulary access of more than 80%
`has been achieved.
`
`In December 2021, Novo Nordisk announced that a contract manufacturer filling syringes for Wegovy® pens for the US
`market temporarily stopped deliveries and manufacturing following issues with current Good Manufacturing Practices. In
`the second quarter of 2022, the contract manufacturer reinitiated production. The 1.7 mg and the 2.4 mg doses of
`Wegovy® are currently available in the market and Novo Nordisk expects to make all Wegovy® dose strengths available in
`the US towards the end of 2022.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 9 of 34
`
`Rare disease
`Rare disease, sales development
`Sales of Rare disease products increased by 6% measured in Danish kroner, and remained unchanged at CER to DKK
`10,581 million.
`
`Rare disease, development per geographical area
`
`Rare disease, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales H1 2022
`DKK million
`10,581
`6,453
`3,489
`297
`2,667
`4,128
`3,787
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 0%
` 1%
` (5%)
` 58%
` 7%
` (1%)
` (2%)
`
`Rare blood disorders
`Sales of Rare blood disorder products increased by 10% measured in Danish kroner and by 3% at CER to DKK 5,940 million.
`The increasing sales were driven by NovoSeven® as well as the launch products Esperoct® and Refixia®.
`
`Sales of haemophilia A products increased by 6% measured in Danish kroner and by 1% at CER to DKK 1,184 million. The
`sales increase was driven by International Operations, partially countered by North America Operations. Esperoct® has
`been launched in 27 countries.
`
`Sales of haemophilia B products increased by 10% measured in Danish kroner and by 6% at CER to DKK 339 million. The
`sales increase was driven by International Operations, partially countered by North America Operations. Refixia® has now
`been launched in 26 countries.
`
`Sales of NovoSeven® increased by 11% measured in Danish kroner and by 3% at CER to DKK 4,289 million. The sales
`development was driven by increasing sales in both North America Operations and International Operations.
`
`Rare endocrine disorders
`Sales of Rare endocrine disorder products decreased by 1% measured in Danish kroner and by 5% at CER to DKK 3,743
`million. The sales decline was driven by North America Operations' sales decreasing by 14% at CER and by International
`Operations sales decreasing by 1% at CER. The sales decline was driven by lower realised prices in the US and timing of
`shipments. Novo Nordisk continues being the leading company in the global human growth disorder market with a value
`market share of 34.0% compared to 32.3% a year ago.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 10 of 34
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 25% measured in Danish kroner and by 16% at CER to DKK 83,296 million in the first six months of
`2022. Sales in International Operations increased by 15% measured in Danish kroner and by 10% at CER. The strategic
`aspiration for International Operations is sales growth between 6-10%. Sales in North America Operations increased by
`36% measured in Danish kroner and by 24% at CER. Compared to the strategic aspiration of transforming 70% of sales in
`the US, 71% of sales are now derived from products launched since 2015.
`
`Sales split per geographical area
`
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
`Total sales
`
` Sales H1 2022
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`
`
`
`
`
`
`
`
`
`42,603
`21,739
`8,407
`12,457
`40,693
`37,874
`
`83,296
`
` 15%
` 14%
` 4%
` 27%
` 36%
` 36%
`
` 25%
`
` 10%
` 12%
` (5%)
` 21%
` 24%
` 23%
`
` 16%
`
` 35%
` 20%
` (4%)
` 19%
` 65%
` 58%
`
` 100%
`
`International Operations
`Sales in International Operations increased by 15% measured in Danish kroner and by 10% at CER. Sales growth was
`driven by most therapy areas with GLP-1 sales growing by 53% at CER, Obesity care sales growing by 60% at CER and Rare
`disease sales growing by 1% at CER, partially countered by insulin sales decreasing by 5%.
`
`EMEA
`Sales in EMEA increased by 14% measured in Danish kroner and by 12% at CER. Sales growth was driven by Diabetes care
`growing by 12% at CER driven by increased GLP-1 sales. Obesity care sales increased by 78% at CER and Rare disease sales
`decreased by 5% at CER.
`
`Region China
`Sales in Region China increased by 4% measured in Danish kroner and decreased by 5% at CER. Sales were driven by
`insulin sales declining by 17% at CER. Insulin sales were negatively impacted by the implementation of Volume Based
`Procurement from May 2022. GLP-1 sales were growing by 83% at CER and Other diabetes care sales decreased by 25% at
`CER.
`
`Rest of World
`Sales in Rest of World increased by 27% measured in Danish kroner and by 21% at CER. Sales growth was driven by
`Diabetes care growing by 25% at CER, reflecting increased GLP-1 and insulin sales, Obesity care sales growing by 29% at
`CER and Rare disease growing by 7% at CER.
`
`North America Operations
`Sales in North America Operations increased by 36% measured in Danish kroner and by 24% at CER. The sales increase
`reflects GLP-1 diabetes sales growing by 41% at CER and Obesity care sales growing by 102% at CER. This was partially
`offset by insulin sales decreasing by 18% at CER driven by lower realised prices due to rebate enhancements and channel
`and payer mix as well as a decline in volume. Rare disease sales decreased by 1% at CER.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 61 / 2022
`
`Novo Nordisk Exhibit 2511
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`Financial report for the period 1 January 2022 to 30 June 2022
`
`Page 11 of 34
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold increased by 14% measured in Danish kroner and by 12% at CER to DKK 12,986 million, resulting in
`a gross margin of 84.4% measured in Danish kroner compared with 83.0% in 2021. The increase in gross margin reflects a
`positive product mix, driven by increased GLP-1 sales, a positive currency impact of 0.8 percentage point and productivity
`improvements. This is partially countered by lower realised prices mainly in the US.
`
`Sales and distribution costs increased by 29% measured in Danish kroner and by 22% at CER to DKK 21,023 million. The
`increase in costs is driven by both International Operations and North America Operations. In International Operations,
`promotional spend is related to launch activities for Ozempic® and Rybelsus® as well as Obesity care market development
`activities. In North America Operations, the cost increase is driven by promotional activities for Ozempic® and market
`development activities for Obesity care. The cost increase is reflecting low activity level in 2021 due to COVID-19 and higher
`distribution costs.
`
`Research and development costs increased by 31% measured in Danish kroner and by 26% at CER to DKK 10,329 million
`reflecting increased late-stage clinical trial activity compared to the first six months of 2021. Increased activities within
`Other serious chronic diseases and GLP-1 are driving the cost increase as well as the operating costs and amortisations
`related to Dicerna Pharmaceuticals Inc. which was acquired in the fourth quarter of 2021.
`
`Administration costs increased by 7% measured in Da